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Improved Stability of a Model IgG3 by DoE-Based Evaluation of Buffer Formulations
Joint Authors
Chavez, Brittany K.
Agarabi, Cyrus D.
Read, Erik K.
Boyne II, Michael T.
Khan, Mansoor A.
Brorson, Kurt A.
Source
Issue
Vol. 2016, Issue 2016 (31 Dec. 2016), pp.1-8, 8 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2016-03-03
Country of Publication
Egypt
No. of Pages
8
Main Subjects
Abstract EN
Formulating appropriate storage conditions for biopharmaceutical proteins is essential for ensuring their stability and thereby their purity, potency, and safety over their shelf-life.
Using a model murine IgG3 produced in a bioreactor system, multiple formulation compositions were systematically explored in a DoE design to optimize the stability of a challenging antibody formulation worst case.
The stability of the antibody in each buffer formulation was assessed by UV/VIS absorbance at 280 nm and 410 nm and size exclusion high performance liquid chromatography (SEC) to determine overall solubility, opalescence, and aggregate formation, respectively.
Upon preliminary testing, acetate was eliminated as a potential storage buffer due to significant visible precipitate formation.
An additional 24 full factorial DoE was performed that combined the stabilizing effect of arginine with the buffering capacity of histidine.
From this final DoE, an optimized formulation of 200 mM arginine, 50 mM histidine, and 100 mM NaCl at a pH of 6.5 was identified to substantially improve stability under long-term storage conditions and after multiple freeze/thaw cycles.
Thus, our data highlights the power of DoE based formulation screening approaches even for challenging monoclonal antibody molecules.
American Psychological Association (APA)
Chavez, Brittany K.& Agarabi, Cyrus D.& Read, Erik K.& Boyne II, Michael T.& Khan, Mansoor A.& Brorson, Kurt A.. 2016. Improved Stability of a Model IgG3 by DoE-Based Evaluation of Buffer Formulations. BioMed Research International،Vol. 2016, no. 2016, pp.1-8.
https://search.emarefa.net/detail/BIM-1097026
Modern Language Association (MLA)
Chavez, Brittany K.…[et al.]. Improved Stability of a Model IgG3 by DoE-Based Evaluation of Buffer Formulations. BioMed Research International No. 2016 (2016), pp.1-8.
https://search.emarefa.net/detail/BIM-1097026
American Medical Association (AMA)
Chavez, Brittany K.& Agarabi, Cyrus D.& Read, Erik K.& Boyne II, Michael T.& Khan, Mansoor A.& Brorson, Kurt A.. Improved Stability of a Model IgG3 by DoE-Based Evaluation of Buffer Formulations. BioMed Research International. 2016. Vol. 2016, no. 2016, pp.1-8.
https://search.emarefa.net/detail/BIM-1097026
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1097026